BR-SIROX

JRCT ID: jRCTs031180263

Registered date:13/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 28/05/2018
• Target sample size: 24
• Study type: Interventional

Intervention(s)

S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer given every 2 weeks.
Surgery will be scheduled after 8 times of S-IROX.

Outcome(s)

• Primary Outcome: R0 Resection rate
• Secondary Outcome: Relapse-free survival, Response rate, Overall survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1 Borderline resectable pancreatic cancer
2 Adenocarcinoma or Adenosquamuscarcinoma
3 Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
4 No treatment history of chemotherapy and chemoradiotherapy
5 No treatment history of chemotherapy and chemoradiotherapy for pancreatic cancer
6 No diarrhea
7 Orally ingestible
8 Appropriate biliary drainage in case of Obstructive jaundice
9 It has neither homozygote (UGT1A1 6/6,UGT1A1 28/28) nor double heterozygote (UGT1A1 6/28).
10 Adequate organ function
1 White blood cell less than 10.000/mm3
2 Neutrophil more than 1.500/mm3
3 Hemoglobin more than 9.0 g/dL
4 Platelet more than 10000/mm3
5 albumin more than 3.0g/dL
6 Total bilirubin less than 1.5mg/dL
7 AST less than 100U/L
8 ALT less than 100U/L
9 Serum creatinine less than 1.2mg/dL(Male), Serum creatinine less than 1.0mg/dL(Femal)
11 Written informed consent
12 Agree with operation

Exclude criteria

1 Multiple primary cancers with disease-free period less than 5 years
2 Active infection
3 Fever more than 38
4 Pregnant
5 Uncontrolled mental disease
6 Continuous administration of immunosuppressive drugs including steroids
7 Interstitial pneumonia
8 Serious complications
9 Unstable angina
10 Continuous administration of flucytosine, phenytoin, warfarin potassium
11 Allergy of contrast agent

Related Information

• Primary Sponsor: Esaki Minoru
• Secondary ID(s): UMIN000033796